Bussolengo, IT · 13 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | Class II | Orthopedic | 6 | 2026-05-19 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Class II | Orthopedic | 2 | 2024-12-03 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | 2 | 2021-04-20 |
| QIH | Automated Radiological Image Processing Software | Class II | Radiology | 1 | 2024-12-19 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | 1 | 2022-01-18 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | 1 | 2020-10-27 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-09-24 | Class II | Ongoing | Z-1977-2025 | REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile | — | Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be … |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-05-19 | K260146 | FITBONE® TRANSPORT AND LENGTHENING SYSTEM | HSB | Class II | Orthopedic |
| 2026-05-08 | K253991 | Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA | HSB | Class II | Orthopedic |
| 2025-04-10 | K250112 | FitboneTM Trochanteric | HSB | Class II | Orthopedic |
| 2024-12-19 | K242270 | OrthoNext Platform System | QIH | Class II | Radiology |
| 2024-12-03 | K242861 | TrueLok Elevate | KTT | Class II | Orthopedic |
| 2024-06-18 | K233867 | Fitbone Trochanteric | HSB | Class II | Orthopedic |
| 2024-05-03 | K232648 | RODEO Telescopic Nail | HSB | Class II | Orthopedic |
| 2024-03-22 | K232169 | FITBONE® Transport and Lengthening System | HSB | Class II | Orthopedic |
| 2022-01-18 | K213572 | JuniOrtho Plating System | HWC | Class II | Orthopedic |
| 2021-11-05 | K212044 | TrueLok Evo | KTT | Class II | Orthopedic |
| 2021-04-20 | K210157 | SOLE Medial Column Fusion Plate | HRS | Class II | Orthopedic |
| 2020-10-27 | K202519 | OrthoNext Platform System | LLZ | Class II | Radiology |
| 2020-05-22 | K200246 | JPS JuniOrtho Plating System | HRS | Class II | Orthopedic |